All documents shown here are included in the seminar for instant download

.

Learn from FDA Warning Letters what inspectors look for and what
mistakes other companies make so you can avoid them

We have several forms that help to implement the procedure consistently
and effectively.

Labcompliance On-line Audio Seminar

This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info
click here
To share this seminar info with your colleagues,
click here..

On-line Audio Seminar 269

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and
FDA&EMA Compliance

Recorded, available with the reference material
at any time

Analyzing biological fluids is one on the most difficult tasks in analytical
laboratories. Most challenging are interferences from matrices and decomposition
products combined with low concentrations of analytes. Correct validation of
bioanalytical methods according to recent FDA and industry recommendations
ensures reliability, consistency and accuracy of bioanalytical data. But because
of the difficult nature of the analysis there are many questions.

Key Questions related to Bioanalytical Method Validation are:

What are FDA and international requirements?

What exactly are the expectations of inspectors?

At what stage of the drug development should the method
being analyzed?

What parameters should be validated?

Which acceptance limits MUST be defined?

How should we document raw and source data?

For how long should we archive validation documentation?

What information should be included in regulatory
submissions?

I want to transfer a method from development to routine lab,
do we need to revalidate?

We want to transfer to an other site, do we need to
revalidate?

How to document bioanalytical method validation for the FDA?

We have slightly changed our method, should we revalidate?

We use software for automated method validation, should it
be Part 11 compliant?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. After the
seminar, an extensive list of reference material like SOPs,
templates and examples will help immediate and cost effective
implementation.

During the interactive presentation you learn about:

FDA regulations and guidelines

Learning from the Crystal City FDA/Industry conference
report

Learning from the FDA and EMA Guidances for Bioanalytical
Method Validation

Phased approach for validation during drug development

Logistics of validation

Development of a master plan and SOP for validation

Preparation and use of reference standards and equipment

Defining parameters and acceptance limits

Defining validation experiments

Documenting and archiving raw and source data

Considerations for Microbiological and Ligand-binding Assays

Working with QC samples for quantitative results

To revalidate or not after method changes

Transferring and using the method to routine

Using computers for automated method validation

Documentation for the FDA and other agencies

And for easy and instant implementation:
download 10+ documents from special seminar website

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.